Bone Loss, Alveolar, Dental Diseases, Dental Trauma, Tooth Loss
Conditions
Keywords
immediate dental implant, dental implant, bone regeneration, peri-implantitis
Brief summary
To evaluate immediate implant placement feasibility and esthetic outcomes in severely damaged sockets that received simultaneously bone reconstruction (cortical bone shield) and implant placement versus intact sockets that needed no reconstruction and had immediate implant placement.
Detailed description
The present clinical trial aims at demonstrating facial bone regeneration on sites that presented large buccal bone dehiscences & vertical bone loss and evaluate the feasibility of performing simultaneous bone augmentation and implant placement, comparing the outcomes with sites that had intact sockets that did not require reconstruction. A secondary objective was to evaluate pink esthetics and marginal bone levels at final follow-up.
Interventions
PROCEDUREimplant placement
autogenous bone reconstruction of damaged socket & simultaneous implant placement
Sponsors
Verdugo, Fernando, DDS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* individuals 20 Years and older * Patients requiring single implants to replace missing teeth to restore masticatory function and esthetics. * ASA1 or ASA2 (American Society of Anesthesiologists) * Healthy individuals with good oral hygiene and motivation * No systemic uncontrolled diseases * Not taking drugs known to modify bone metabolism
Exclusion criteria
* Individuals with untreated & generalized severe periodontitis * Smokers (\>5 cigarettes/day) * Poor oral hygiene * Diabetes (HbA1C \>6.5% as cutoff value) * Uncontrolled cardiovascular disease * Poor overall health (ASA IV)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate implant placement feasibility & success rate at 12 months | 12 months | evaluate implant success following Karoussis et al. success criteria |
| Number of individuals with low pink esthetic outcomes as assessed by pink esthetic scores (PES) | 12 months | pink esthetics scores (PES) as proposed by Belser et al. Values 0-10 were 10 is the best esthetic outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Implant transparency: clinical presence or absence | 12 months | Visual evaluation of facial mucosal implant transparency at 12 months: positive or negative |
| Number of participants with >0.2mm of marginal bone levels | 12 months | evaluate radiographic marginal bone levels at 12 months with \>0.2mm of bone loss |
| Band of keratinized tissue: clinical presence or absence | 12 months | evaluate the presence of facial keratinized tissue on the implant sites \>2 or \<2mm |
Countries
United States
Outcome results
None listed